Vedolizumab IV 300 mg in the Treatment of Chronic Pouchitis (EARNEST)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)
IRAS ID
204455
Contact name
Simon Travis
Contact email
Sponsor organisation
Takeda Development Centre Europe, Ltd.
Eudract number
2015-003472-78
Clinicaltrials.gov Identifier
009125, IND Number:
Duration of Study in the UK
3 years, 0 months, 00 days
Research summary
The surgical treatment of choice for patients with ulcerative colitis (UC) is removal of the colon followed by construction of an ileal pouch. Inflammation of the “pouch,” commonly called pouchitis, is the most common long-term complication in these patients and is characterized by watery, sometimes bloody stool associated with urgency, incontinence, abdominal cramps, malaise, and fever. While pouchitis usually responds to short-term antibiotic therapy, some patients experience recurrent pouchitis and require chronic antibiotic therapy to sustain remission or the more drastic option of surgical removal of the pouch. Chronic or recurrent pouchitis is often managed with long-term antibiotic administration, with metronidazole and ciprofloxacin being the antibiotics most often prescribed. There are presently no approved drugs for the treatment or prevention of pouchitis in the United States or Europe. Thus, a large unmet medical need exists in the management of refractory pouchitis. This research study will evaluate the safety and efficacy after treatment with vedolizumab (the medication being tested in this study) compared to placebo (saline which does not contain any active ingredients) in patients who have developed chronic or recurrent pouchitis within 1 year of screening visit or requiring continuous antibiotics.
Approximately 200 patients will be randomly assigned to one of 2 treatment groups.
• Group 1 will receive vedolizumab 300 mg IV at Weeks 0, 2, 6, 14, 22, and 30.
• Group 2 will receive placebo IV at Weeks 0, 2, 6, 14, 22, and 30.The study includes up to a 4-week screening period, a 34-week treatment period (with last dose at Week 30), and an 18-week follow-up period following last dose. Patients will need to visit the clinic approximately 10 times for the study over a 52-week period depending on the scheduling of their study procedures.
The study will be conducted in NHS hospitals throughout UK and other countries in the world.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0379
Date of REC Opinion
22 Aug 2016
REC opinion
Further Information Favourable Opinion